Israel's SciSparc Initiates Clinical Trial of SCI-210 for Autism in Pediatrics

02 October 2023 | Monday | News

SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare disease of the central nervous system, announced the initiation of a pivotal clinical trial for its drug candidate, SCI-210, at the Soroka University Medical Center. SCI-210 is designed to help control symptoms of Autism Spectrum Disorder (“ASD”) and is an innovative proprietary combination of cannabidiol (“CBD”) and SciSparc's Palmitoylethanolamide (PEA), the active ingredient of its proprietary CannAmide™.
Image Source | Public Domain

Image Source | Public Domain

The study will evaluate the safety, tolerability, and efficacy of SCI-210, in comparison to CBD monotherapy in treating ASD. Designed as a randomized, double-blind, placebo-controlled trial with a cross-over study, the trial will span 20 weeks and involve 60 children between 5-18 years old. The trial’s primary efficacy endpoints include three rigorous assessments: the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire; the Clinical Global Impressions-Improvement (CGI-I) scale, administered by healthcare professionals; and the determination of the effective therapeutic dosage.

Oz Adler, Chief Executive Officer of SciSparc weighed in on the significance of the trial, stated, "The initiation of this clinical trial signifies a major leap forward in our collective effort to understand and effectively treat ASD. Partnering with the National Autism Research Center, Israel's foremost authority on autism research, underscores our unwavering commitment to scientific rigor and patient safety. Our goals are to create an effective and safe treatment for ASD and to improve the quality of life for these children and their families. We are optimistic that SCI-210 could be a game-changer in ASD treatment."

The trial was designed in collaboration with the National Autism Research Center, Israel's leading institution for autism research.

The Soroka University Medical Center, one of the most prestigious healthcare institutions in Israel, will host the study. This location offers an advanced clinical setting, coupled with a multidisciplinary team of experts in neurology and developmental disorders, which the Company believes demonstrates the trial's high scientific and ethical standards.

ASD is a neurodevelopmental condition that profoundly impacts social interaction and communication skills. The term "spectrum" in Autism Spectrum Disorder encapsulates the wide array of symptoms and severity levels associated with this complex condition.

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